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Last Updated: March 19, 2024

LEVITRA Drug Patent Profile


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Which patents cover Levitra, and what generic alternatives are available?

Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has fifty-four patent family members in thirty-one countries.

The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Drug patent expirations by year for LEVITRA
Drug Prices for LEVITRA

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Drug Sales Revenue Trends for LEVITRA

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Recent Clinical Trials for LEVITRA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Respira Therapeutics, Inc.Phase 1
Tritech Biopharmaceuticals Co., Ltd.Phase 1/Phase 2
A2 Healthcare Taiwan CorporationPhase 1/Phase 2

See all LEVITRA clinical trials

Paragraph IV (Patent) Challenges for LEVITRA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LEVITRA Tablets vardenafil hydrochloride 2.5 mg 021400 1 2009-09-04
LEVITRA Tablets vardenafil hydrochloride 5 mg and 10 mg 021400 1 2009-07-10
LEVITRA Tablets vardenafil hydrochloride 20 mg 021400 1 2009-03-05

US Patents and Regulatory Information for LEVITRA

LEVITRA is protected by one US patents.

Patents protecting LEVITRA

Medicaments containing vardenafil hydrochloride trihydrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LEVITRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-002 Aug 19, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LEVITRA

See the table below for patents covering LEVITRA around the world.

Country Patent Number Title Estimated Expiration
Hungary 228196 2-PHENYL SUBSTITUTED IMIDAZOTRIAZINONES, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS THEREOF ⤷  Try a Trial
Slovenia 1049695 ⤷  Try a Trial
El Salvador 1998000135 IMIDAZOTRIAZINONAS SUSTITUIDAS POR 2-FENILO REF. LEA 32733-SV ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.